EA036623B1 - Стабильные белковые композиции - Google Patents

Стабильные белковые композиции Download PDF

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Publication number
EA036623B1
EA036623B1 EA201890979A EA201890979A EA036623B1 EA 036623 B1 EA036623 B1 EA 036623B1 EA 201890979 A EA201890979 A EA 201890979A EA 201890979 A EA201890979 A EA 201890979A EA 036623 B1 EA036623 B1 EA 036623B1
Authority
EA
Eurasian Patent Office
Prior art keywords
protein
peg
phase
dosage form
concentration
Prior art date
Application number
EA201890979A
Other languages
English (en)
Russian (ru)
Other versions
EA201890979A1 (ru
Inventor
Хантер Чен
Эрика Шлезингер
Original Assignee
Ридженерон Фармасьютикалз, Инк.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ридженерон Фармасьютикалз, Инк. filed Critical Ридженерон Фармасьютикалз, Инк.
Publication of EA201890979A1 publication Critical patent/EA201890979A1/ru
Publication of EA036623B1 publication Critical patent/EA036623B1/ru

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0048Eye, e.g. artificial tears
    • A61K9/0051Ocular inserts, ocular implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L71/00Compositions of polyethers obtained by reactions forming an ether link in the main chain; Compositions of derivatives of such polymers
    • C08L71/08Polyethers derived from hydroxy compounds or from their metallic derivatives
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2203/00Applications
    • C08L2203/02Applications for biomedical use

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Polymers & Plastics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Peptides Or Proteins (AREA)
EA201890979A 2015-10-16 2016-10-14 Стабильные белковые композиции EA036623B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562242412P 2015-10-16 2015-10-16
PCT/US2016/057019 WO2017066554A1 (en) 2015-10-16 2016-10-14 Stable protein compositions

Publications (2)

Publication Number Publication Date
EA201890979A1 EA201890979A1 (ru) 2018-10-31
EA036623B1 true EA036623B1 (ru) 2020-12-01

Family

ID=57209897

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201890979A EA036623B1 (ru) 2015-10-16 2016-10-14 Стабильные белковые композиции

Country Status (13)

Country Link
US (1) US20180289623A1 (enExample)
EP (1) EP3362041A1 (enExample)
JP (3) JP6853245B2 (enExample)
KR (1) KR102731879B1 (enExample)
CN (2) CN113827704B (enExample)
AU (2) AU2016340072B2 (enExample)
CA (1) CA3001346A1 (enExample)
EA (1) EA036623B1 (enExample)
IL (2) IL258570B2 (enExample)
MX (2) MX390837B (enExample)
MY (2) MY199546A (enExample)
WO (1) WO2017066554A1 (enExample)
ZA (1) ZA201802460B (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2909777T3 (es) 2011-11-18 2022-05-10 Regeneron Pharma Formulación de liberación prolongada que comprende micropartículas para su uso en el humor vítreo del ojo para tratar trastornos oculares vasculares
IL258570B2 (en) * 2015-10-16 2024-07-01 Regeneron Pharma Stable protein preparations
US12156900B2 (en) 2017-11-17 2024-12-03 Amgen Inc. VEGFR-Fc fusion protein formulations
PT4364724T (pt) 2018-05-10 2025-12-16 Regeneron Pharma Formulações contendo uma proteína de fusão do recetor do vegf de concentração elevada
US20220054586A1 (en) * 2018-09-10 2022-02-24 Samsung Bioepis Co., Ltd. Liquid composition comprising protein
CN112294760B (zh) * 2019-07-26 2025-12-12 宁波新致生物科技有限公司 一种液体制剂及其应用
WO2025235973A1 (en) * 2024-05-09 2025-11-13 Deep Brain Bci Corporation Implantable medical devices for delivering therapeutics and brain-computer interface systems

Citations (1)

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Publication number Priority date Publication date Assignee Title
US20120095439A1 (en) * 2010-01-29 2012-04-19 De Juan Jr Eugene Implantable therapeutic device

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JP3756512B2 (ja) * 1992-09-21 2006-03-15 ファルマシア・アンド・アップジョン・カンパニー・エルエルシー 徐放性タンパク質製剤
US6004549A (en) * 1994-12-14 1999-12-21 Schering Corporation Crystalline protein controlled release compositions
RU2357750C2 (ru) * 2002-12-31 2009-06-10 Элтус Фармасьютикалз Инк. Кристаллы человеческого гормона роста и способы их получения
CA2530113C (en) * 2003-06-26 2013-08-13 Control Delivery Systems, Inc. Bioerodible sustained release drug delivery systems
CA2588449A1 (en) * 2004-11-24 2006-06-01 Therakine Corporation An implant for intraocular drug delivery
CN104434770A (zh) 2006-06-16 2015-03-25 瑞泽恩制药公司 适合玻璃体内施用的vegf拮抗剂的制剂
WO2008109886A1 (en) 2007-03-08 2008-09-12 The Regents Of The University Of California Topographically engineered structures and methods for using the same in regenerative medicine applications
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SG173167A1 (en) * 2009-01-29 2011-08-29 Forsight Labs Llc Posterior segment drug delivery
CN101559041B (zh) * 2009-05-19 2014-01-15 中国科学院过程工程研究所 粒径均一的多肽药物缓释微球或微囊制剂及制备方法
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KR101808234B1 (ko) 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
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Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
US20120095439A1 (en) * 2010-01-29 2012-04-19 De Juan Jr Eugene Implantable therapeutic device

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
ATHA D H, INGHAM K C: "MECHANISM OF PRECIPITATION OF PROTEINS BY POLY ETHYLENE GLYCOLS ANALYSIS IN TERMS OF EXCLUDED VOLUME", JOURNAL OF BIOLOGICAL CHEMISTRY.(MICROFILMS), AMERICAN SOCIETY OF BIOLOGICAL CHEMISTS, BALTIMORE, MD., US, vol. 256, no. 23, 1 January 1981 (1981-01-01), US, pages 12108 - 12117, XP002454548 *
SANDRA HERRMANN ; SILKE MOHL ; FLORENCE SIEPMANN ; JUERGEN SIEPMANN ; GERHARD WINTER: "New Insight into the Role of Polyethylene Glycol Acting as Protein Release Modifier in Lipidic Implants", PHARMACEUTICAL RESEARCH, KLUWER ACADEMIC PUBLISHERS-PLENUM PUBLISHERS, NL, vol. 24, no. 8, 23 March 2007 (2007-03-23), NL, pages 1527 - 1537, XP019507255, ISSN: 1573-904X, DOI: 10.1007/s11095-007-9271-y *

Also Published As

Publication number Publication date
MX2018004695A (es) 2019-03-14
BR112018007507A2 (pt) 2018-10-23
JP2018538243A (ja) 2018-12-27
JP7179112B2 (ja) 2022-11-28
JP6853245B2 (ja) 2021-03-31
CA3001346A1 (en) 2017-04-20
AU2016340072B2 (en) 2021-10-28
MX2022003376A (es) 2022-04-12
KR102731879B1 (ko) 2024-11-20
JP7547438B2 (ja) 2024-09-09
IL258570B1 (en) 2024-03-01
AU2022200475B2 (en) 2023-09-14
JP2021098742A (ja) 2021-07-01
WO2017066554A1 (en) 2017-04-20
EA201890979A1 (ru) 2018-10-31
CN113827704A (zh) 2021-12-24
ZA201802460B (en) 2024-09-25
MY193964A (en) 2022-11-03
US20180289623A1 (en) 2018-10-11
IL258570A (en) 2018-05-31
IL310557A (en) 2024-03-01
IL258570B2 (en) 2024-07-01
KR20180063311A (ko) 2018-06-11
JP2023025046A (ja) 2023-02-21
AU2016340072A1 (en) 2018-05-10
CN108348462B (zh) 2021-10-15
MX390837B (es) 2025-03-21
CN113827704B (zh) 2024-07-12
EP3362041A1 (en) 2018-08-22
MY199546A (en) 2023-11-06
AU2022200475A1 (en) 2022-02-17
CN108348462A (zh) 2018-07-31

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